FDA Grants Priority Review to CPX-351 for AML

June 1, 2017 – The FDA has accepted a new drug application (NDA) from Jazz Pharmaceuticals, granting priority review to the company’s novel CPX-351 injection for acute myeloid leukemia (AML). CPX-351 is an investigational nano-scale liposome co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio. Priority review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. The designation … (leggi tutto)